1. (a) No person or business entity shall establish, conduct, operate or maintain a blood collection facility unless such person or business entity holds a license issued by the department in accordance with section 19a-36-F2 of the Regulations of Connecticut State Agencies. Prior to issuance of such license, the applicant shall secure the applicable CLIA certificate, or a CLIA certificate of waiver, if applicable, required to establish, conduct, operate or maintain such facility.
2. (b) A source plasma donation center shall not be required to obtain a blood collection facility license pursuant to this section if such center is not performing the function of a blood collection facility as provided in section 19a-490(t) of the Connecticut General Statutes.
3. (c) A hospital licensed under chapter 368v of the Connecticut General Statutes shall not be required to obtain a license as a blood collection facility for blood component collection activities that take place on the hospital campus, as defined in section 19a-508c of the Connecticut General Statutes.
4. (d) Approval for licensure as a blood collection facility pursuant to this section shall exempt such facility that collects and sells for secondary use any single donor products, including blood components that do not meet the definition of source plasma, from requirements for additional licensure as a source plasma donation center.
5. (e) Approval for licensure as a blood collection facility pursuant to this section shall exempt such facility that conducts solely waived tests and has a current CLIA certificate of waiver from requirements for licensure as a clinical laboratory. A licensed clinical laboratory shall require separate licensure as a blood collection facility to conduct those functions provided in section 19a-490(t) of the Connecticut General Statutes.
6. (f) A mobile or temporary blood collection facility shall not require additional licensure provided that the person or business entity operating said facility is otherwise licensed in this state as a blood collection facility in accordance with this section.

7. (g) Application for initial or renewal licensure.

   1. (1) Application for initial or renewal licensure shall be made by the applicant in a form and manner prescribed by the department. No blood collection shall be conducted until the applicant has been notified by the department that the license is approved and in effect. No blood collection shall be conducted after the expiration of a license or if a license has been suspended, denied or revoked.

   2. (2) Each application for initial or renewal licensure shall include, but not be limited to, the following:

      1. (A) Name and address of the facility;
      2. (B) Statement of ownership and operation, including name and address of the applicant or licensee, and name and address of legal operating entity, parent organization, or both, as applicable;
      3. (C) Name, address and qualifications of the director;
      4. (D) Business identification number issued by the Secretary of the State;
      5. (E) Certificates of malpractice and public liability insurance;
      6. (F) Current CLIA certificate or CLIA certificate of waiver;
      7. (G) A list of proposed services offered;
      8. (H) A list of reference laboratories to be used;
      9. (I) Policies and procedures required as described in section 19a-36-F3 of the Regulations of Connecticut State Agencies;
      10. (J) A roster of qualified personnel to be employed or under contract to meet the personnel requirements as described in section 19a-36-F5 of the Regulations of Connecticut State Agencies;
      11. (K) The licensure or renewal licensure fees provided in section 19a-565(f) of the Connecticut General Statutes; and(L) Such additional information as the department may require.

   3. (3) Inspection.

      1. (A) Upon determination that the application materials are complete, the department shall notify the applicant of inspection. The applicant shall make the premises, facilities, equipment, policies and procedures required under section 19a-36-F3 of the Regulations of Connecticut State Agencies and records available for department inspection upon request of the department, and shall make personnel available for interviews.
      2. (B) The commissioner may, in the commissioner’s discretion, waive inspection upon renewal of a license issued under this section, if the commissioner elects to accept a favorable and timely accreditation assessment report conducted by an accreditation organization. In the event of any corrective action plan under such accreditation, the department shall review such plan and evidence of remediation and may require completion of the implementation of the plan before a license will be granted.

   4. (4) Issuance or renewal of license.

      1. (A) The department may issue a license or renew a license to operate a blood collection facility if the commissioner determines following inspection that the facility is in compliance with the statutes and regulations pertaining to its licensure.
      2. (B) The commissioner shall issue a license to the blood collection facility in the name of the applicant. The license shall not be transferable or assignable.
      3. (C) A licensee operating a blood collection facility licensed pursuant to this section with more than one permanent location shall require a separate license for each permanent location.
      4. (D) The licensee shall post the license in a conspicuous location at each location of the blood collection facility.
      5. (E) A license issued under this section shall be renewed biennially. Applications for renewal shall be submitted to the department not later than four months prior to the expiration of the current license.

8. (h) Denial of a license. The commissioner may, in the commissioner’s discretion, deny an initial or renewal application for licensure for any of the following reasons:

   1. (1) The applicant or licensee has failed to comply with applicable federal, state or local laws;
   2. (2) Failure of the blood collection facility to permit department inspection of the premises or access to the facility’s records upon request of the department;
   3. (3) If licensure would pose a threat to the health, safety or well-being of the public; or(4) There is a material misstatement of fact on the application.
9. (i) Change in ownership. Any change in ownership of a blood collection facility licensed pursuant to this section shall be made in compliance with section 19a-493 of the Connecticut General Statutes.
10. (j) Change in facilities. Any blood collection facility licensed pursuant to this section proposing an expansion or alteration of its facility shall notify the department at least thirty days prior to enacting any such expansions or alterations.

11. (k) Change or absence of director. Any blood collection facility licensed pursuant to this section proposing a change in director shall notify the department at least thirty days prior to such change. In the event of an unplanned change in director, or the absence of a director for a period of more than thirty days, the licensee shall notify the department in writing within twenty-four hours of the date the licensee receives notice of such unplanned change or absence greater than thirty days. In the event of an unplanned change or absence greater than thirty days the licensee may designate an interim director who meets the qualifications set forth in section 19a-36-F5(c)(3) of the Regulations of Connecticut State Agencies for a period of up to six weeks.

    1. (1) The commissioner may waive provisions of sections 19a-36-F2 to 19a-36-F6, inclusive, of the Regulations of Connecticut State Agencies as provided in section 19a-495 of the Connecticut General Statutes.

    2. (2) The licensee requesting a waiver shall do so in a form and manner prescribed by the commissioner. Such request shall include:

       1. (A) The specific regulations for which the waiver is requested;
       2. (B) Reasons for requesting a waiver, including a statement of the type and degree of hardship that would result to the blood collection facility upon enforcement of the regulations;
       3. (C) The specific relief requested;
       4. (D) Any documentation that supports the request for waiver; and(E) Alternative policies and procedures proposed.

    3. (3) In determining whether to grant or deny a waiver, the commissioner may consider:

       1. (A) The impact of a waiver on services provided; and(B) Alternative policies or procedures proposed by the blood collection facility.
    4. (4) The commissioner may request additional information before determining whether to grant or deny the request for a waiver.

    (l) Waiver.

(Effective March 19, 2025)